5.4
15.0
26.4
22.5
26.0
20.1
Skeletal Pain
61.0
71.7
70.0
75.4
66.8
74.0
CNS
Anxiety
7.8
9.1
18.0
16.8
14.3
14.3
Headache
24.4
19.8
27.2
23.6
26.2
22.3
Insomnia
17.1
17.2
25.1
19.4
22.2
19.0
Respiratory System
Coughing
26.3
22.5
25.3
19.7
25.7
20.6
Dyspnea
22.0
21.4
35.1
24.4
30.4
23.4
Pleural Effusion
2.9
4.3
15.0
9.1
10.7
7.5
Sinusitis
14.6
16.6
16.1
10.4
15.6
12.0
Upper Respiratory Tract Infection
32.2
28.3
19.6
20.2
24.1
22.9
Urogenital System
Urinary Tract Infection
15.6
9.1
20.2
17.6
18.5
15.6
Of the toxicities commonly associated with chemotherapy, the frequency of vomiting, anorexia, and anemia were slightly more common in the pamidronate disodium patients whereas stomatitis and alopecia occurred at a frequency similar to that in placebo patients. In the breast cancer trials, mild elevations of serum creatinine occurred in 18.5% of pamidronate disodium patients and 12.3% of placebo patients. Mineral and electrolyte disturbances, including hypocalcemia, were reported rarely and in similar percentages of pamidronate disodium-treated patients compared with those in the placebo group. The reported frequencies of hypocalcemia, hypokalemia, hypophophatemia, and hypomagnesemia for pamidronate disodium-treated patients were 3.3%, 10.5%, 1.7%, and 4.4%, respectively, and for placebo-treated patients were 1.2%, 12%, 1.7%, and 4.5%, respectively. In previous hypercalcemia of malignancy trials, patients treated with pamidronate disodium (60 or 90 mg over 24 hours) developed electrolyte abnormalities more frequently (see ADVERSE REACTIONS, Hypercalcemia of Malignancy).
Arthralgias and myalgias were reported slightly more frequently in the pamidronate disodium group than in the placebo group (13.6% and 26% vs 10.8% and 20.1%, respectively).
In multiple myeloma patients, there were five pamidronate disodium-related serious and unexpected adverse experiences. Four of these were reported during the 12 month extension of the multiple myeloma trial. Three of the reports were of worsening renal function developing in patients with progressive multiple myeloma or multiple myeloma-associated amyloidosis. The fourth report was the adult respiratory distress syndrome developing in a patient recovering from pneumonia and acute gangrenous cholecystitis. One pamidronate disodium-treated patient experienced an allergic reaction characterized by swollen and itchy eyes, runny nose, and scratchy throat within 24 hours after the sixth infusion.
In the breast cancer trials, there were four pamidronate disodium-related adverse experiences, all moderate in severity, that caused a p
